Fda Approves New Type Of Non-opioid Pain Medication, 1st Of Its Kind In More Than 20 Years
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The drug is for moderate to severe acute pain.
The U.S. Food and Drug Administration (FDA) on Thursday approved a new type of prescription pain medication for moderate to severe acute pain.
The drug, called Suzetrigine and manufactured by biotech company Vertex Pharmaceuticals, is a non-opioid pain killer, which doesn’t have addictive properties, unlike opioids often used for this type of pain.
This is the first class of non-opioid pain medication approved to treat moderate to severe acute pain by the FDA in more than 20 years.
"Suzetrigine's approval could transform pain management and advance safer treatment paradigms," Dr. Jianguo Cheng, a professor of anesthesiology and medical director of the Cleveland Clinic Consortium for Pain at Cleveland Clinic, who was not involved in the clinical trials, told ABC News.
In two clinical trials, tested on adults between ages 18 and 80, Suzetrigine was found to reduce moderate to severe acute pain for adults from baseline by about 50% in 48 hours in two clinical trials.
The average time to meaningful pain relief ranged from two to four hours, compared to eight hours in the placebo group.
Suzetrigine works by inhibiting the NaV1.8 pain signal in the peripheral nervous system. This channel is not expressed in the brain or anywhere else in the central nervous system, therefore the drug does not have addictive properties like opioids do and does not have overdose potential, according to Vertex.
Suzetrigine was found to be as similarly effective as hydrocodone, an opioid pain medication, for reducing acute pain, with the added benefit of being a non-opioid and non-addictive drug.
In another clinical trial, the drug was tested in patients with a broader range of surgical and non-surgical acute pain conditions and was found to be safe and effective.
More than 80% of patients in this clinical trial rated Suzetrigine as a good, very good or excellent pain medication when investigating multiple acute pain types.
"Suzetrigine offers a safer option for managing moderate-to-severe acute pain, reducing reliance on opioids," Cheng said. It offers rapid relief and can be integrated into postoperative pain protocols or acute pain scenarios where immediate relief is critical."
"By managing acute pain effectively, Suzetrigine may help prevent the transition to chronic pain, reducing the need for long-term pain management strategies," he added.